A Phase 4 interventional study of Dapagliflozin (5-10 mg daily) - SGLT2 Inhibitor Therapy and Sitagliptin (DPP4 inhibitor) in Breast Cancer, sponsored by Tanta University. Not yet recruiting. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-27.
Sponsored by Tanta University · Phase 4, Interventional, and Prevention
Background:
Breast cancer is the most frequently diagnosed malignancy among women worldwide and a major cause of morbidity and mortality. Anthracycline-based chemotherapy, particularly doxorubicin, remains a cornerstone of treatment; however, its clinical utility is limited by dose-dependent cardiotoxicity that can lead to irreversible cardiac dysfunction and heart failure. The search for effective cardioprotective interventions is therefore a key priority in cardio-oncology.
Aim:
This study aims to compare the efficacy of sodium-glucose cotransporter 2 (SGLT2) inhibitors and dipeptidyl peptidase-4 (DPP-4) inhibitors in preventing doxorubicin-induced cardiotoxicity in Egyptian women with breast cancer.
Methods:
A prospective, randomized, controlled clinical trial will be conducted at Oncology Hospital of Tanta University. Eligible adult female patients with histologically confirmed breast cancer scheduled to receive anthracycline-containing chemotherapy will be randomized into three groups: (1) control (standard care), (2) SGLT2 inhibitor group (dapagliflozin 10-25 mg daily), and (3) DPP-4 inhibitor group (sitagliptin 50-100 mg daily). Treatment will start five days before the first chemotherapy cycle and continue for six months, with follow-up for an additional six months. Cardiac function will be assessed by echocardiography (LVEF and GLS) and biomarkers (Cardiac Troponin T, and NT-proBNP). The primary endpoint is the incidence of cardiotoxicity defined by a ≥10% decline in LVEF to \<50% or a >15% relative decline in GLS accompanied by biomarker elevation.
Expected Outcomes:
It is anticipated that both SGLT2 and DPP-4 inhibitors will reduce the incidence and severity of doxorubicin-induced cardiotoxicity, with SGLT2 inhibitors expected to demonstrate superior cardioprotective efficacy. Findings from this study may support the integration of cardioprotective antidiabetic agents into oncology care pathways to improve the cardiac outcomes and overall survival of breast cancer patients.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 150 is above the median of 72 across 9,302 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Tanta University is the lead sponsor of 963 studies on the registry; 304 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Type 1 and type 2 diabetes; history of diabetic ketoacidosis; pregnancy/lactation.
Usual care without prophylactic cardioprotective agent (guideline directed initiation permitted if clinically indicated post randomization; recorded and adjusted for).
Other: Standard Care (in control arm)
Dapagliflozin 10 mg orally once daily (dose may increase to 25 mg if tolerated after Cycle 1) starting ≥5 days before first DOX dose and continued for 3 months.
Drug: Dapagliflozin (5-10 mg daily) - SGLT2 Inhibitor Therapy
Sitagliptin 100 mg orally once daily (50 mg if eGFR 30-45 mL/min/1.73m²) starting ≥5 days before first DOX dose and continued for 3 months.
Drug: Sitagliptin (DPP4 inhibitor)
Dapagliflozin 10 mg orally once daily (dose may increase to 25 mg if tolerated after Cycle 1) starting ≥5 days before first DOX dose and continued for 3 months.
Sitagliptin 100 mg orally once daily (50 mg if eGFR 30-45 mL/min/1.73m²) starting ≥5 days before first DOX dose and continued for 3 months.
Usual care without prophylactic cardioprotective agent (guideline directed initiation permitted if clinically indicated post randomization; recorded and adjusted for).
Percentage of participants experiencing cardiotoxicity
Cardiotoxicity will be defined as the occurrence of any of the following during the study period: A decline in left ventricular ejection fraction (LVEF) ≥ 10% from baseline resulting in an LVEF \< 50%, as measured by echocardiography, or A relative reduction in global longitudinal strain (GLS) \> 15% from baseline, as assessed by speckle-tracking echocardiography. Unit of Measure: Percentage of participants experiencing cardiotoxicity (%)
Time frame: Within 3 months from initiation of therapy.
Percentage Change in Left Ventricular Ejection Fraction (LVEF)
Description: Absolute change in left ventricular ejection fraction from baseline to 3 months, measured by transthoracic echocardiography. Unit of Measure: Percentage points (%)
Time frame: 3 months
Percentage Change in Global Longitudinal Strain (GLS)
Description: Relative percentage change in global longitudinal strain from baseline to 3 months, assessed using speckle-tracking echocardiography. Unit of Measure: Percentage (%)
Time frame: 6 months
Time to cardiotoxicity and HF hospitalization through 6 months.
Time frame: 6 months
Change in serum cardiac biomarker levels e.g., troponin
Change in Cardiac Biomarkers (if applicable) Description: Change in serum cardiac biomarker levels (e.g., troponin) from baseline to 3 months. Troponin: ng/L
Time frame: 3 months
Change in serum cardiac biomarker levels (e.g., NT-proBNP)
Description: Change in serum cardiac biomarker levels (e.g., NT-proBNP) from baseline to 3 months. NT-proBNP: pg/mL
Time frame: 3 months
All cause mortality and cancer therapy interruptions due to cardiac reasons.
Time frame: 6 months
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
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